Director IRB Ops

Job Description: The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required of this position. Essential Responsibilities In collaboration with the IRB Manager, manages all CCI-IRB staff, their work product, handles employee relations issues with Human Resources as needed, and all other administrative aspects of the office. Provides guidance and consultation to CCI board members and staff, and to investigators and research staff, regarding current issues and ethical concerns in human subject protection, including guidance on associated HHS, FDA, and institutional regulations, policies, procedures, and guidelines. Consults with Committee Chair and administratively manages and coordinates Chair/Vice-chair reviewer schedules, establishes guidelines for reviewer consistency. Works with Committee Chair to establish review consistency across full board and continuing review board activities and performs IRB Vice Chair and committee member evaluations. Contributes significant administrative and regulatory comments to pre-review of continued protocols. Provides oversight for the workflow and submission of BILH protocols being submitted to the BIDMC IRB for review. Provides guidance for institutional reviews at the home institution and ensures non-compliance is communicated with home institutional leadership. Works with the Chair, Vice Chairs, Institutional Official, and HRPP Director to formulate short-term and long-term goals and objectives for the CCI and administrative staff, including planning the annual IRB retreat. Prepares training materials, revises forms and documents, web content and other materials as needed to ensure adherence to regulations and policies. Maintains IRB committee membership in accordance with regulations, assuring breadth of experience, expertise, and diversity, and orients new IRB members. Serves as a key member of the IRB Executive Committee, the Vice Chair Committee, and the Conflict of Interest Committee, and is the key user representative on IRB system changes. Updates HRPP Director when reports/updates must be made to BIDMC research community, other institutional departments, and external regulatory agencies. Has the authority to direct and support managers with functional area responsibilities and is responsible for hiring, termination, corrective action, and performance reviews. Directs more than 7 direct reports and 1-5 indirect reports. Assists in planning, monitoring, and/or managing the budget in the functional area of the department. Required Qualifications Bachelor’s degree required; Master’s degree preferred. 8-10 years of related work experience in Human Subjects Research, including 3-5 years of supervisory/management experience. Advanced skills with Microsoft applications (Outlook, Word, Excel, PowerPoint or Access) and other web-based applications. Ability to produce complex documents, perform analysis, and maintain databases. Preferred Qualifications CIP certification. Competencies Decision Making – Ability to make decisions guided by precedents, policies, and objectives, and to recommend on issues affecting a department. Problem Solving – Ability to address highly varied, complex, and often non-recurring problems, requiring staff input, innovative, and creative diagnostic techniques. Independence of Action – Ability to set direction, priorities, develop policies, and allocate resources for major or multiple departments. Written Communications – Ability to communicate complex information in English effectively in writing to all staff levels, management, and external customers. Oral Communications – Ability to verbally communicate complex concepts, resolve conflicts, negotiate, motivate, and persuade others. Knowledge – Ability to demonstrate in-depth knowledge of concepts, practices, and policies and apply them in complex situations. Team Work – Ability to lead small projects or work groups, create a collaborative environment, and improve workflows. Customer Service – Ability to lead operational initiatives to meet or exceed customer service standards in assigned units or multiple areas. Social/Environmental Requirements Work requires periods of close attention without interruption. Concentrated effort up to 4 hours without break may be required. Work is varied daily and requires adaptability to respond to changes and independent judgment. No substantial exposure to adverse environmental conditions. Health Care Status IHCW: No patient contact, but regular handling of specimens for testing and diagnostics. Health Care Worker Status may vary by department. Sensory Requirements Close work (paperwork, visual examination), monitor use, visual monotony, visual clarity Physical Requirements Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, walking and standing required only occasionally. Endurance: working up to 3-4 hours without a break, frequent sitting, keyboard use. Pay Range

$155,002.00 USD – $184,995.00 USD

The pay range listed for this position is the annual base salary range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, which may include seniority, education, training, relevant experience, relevant certifications, geographic location, job responsibilities, or other applicable factors permissible by law. Vaccination Requirement As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) as a condition of employment. Equal Opportunity Employer Equal Opportunity Employer/Veterans/Disabled #J-18808-Ljbffr Beth Israel Lahey Health